Chronic Kidney DiseasesRESURRECTNCT05703620
REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions.
A study testing Renal Denervation in people with Chronic Kidney Diseases and Heart Failure, run by Royal Perth Hospital at 1 site in Australia.
Trial summary
The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, Heart Failure, End Stage Renal Disease
- What is being tested?
- Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Oct 2021to 18 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both Male and female patients
- Ages between 18-75 years of age
- Individual is competent and willing to provide written, informed consent to participate in this clinical study with either
- CKD stage 3a/b or
- ESRD on stable renal replacement therapy or
- Mild to moderate heart failure with reduced ejection fraction
Who cannot join
- Ineligible anatomy
- Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device.
- Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
- Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
- Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
- Individual has been admitted for inpatient hospitalization for decompensated HF in the previous month
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- Female participants of childbearing potential must have a negative pregnancy test prior to treatment.
- Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual is currently enrolled in another investigational drug or device trial. Note: For the purpose of this protocol, participants involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.
- Individual has a disease or condition (aside from CKD, ESRD, and HFrEF) that may limit their life expectancy to < 1 year.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Anu Joyson, 92240390, anu.joyson@uwa.edu.au
Markus Schlaich, Prof, 92240382 ext. Schlaich, markus.schlaich@uwa.edu.au
About this study
Official title: REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions - the RESURRECT Trial. A Pilot Proof-of-concept and Safety Study With the Paradise Denervation System
The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)
Read the detailed description
There is unequivocal evidence for an important contribution of increased renal sympathetic nerve activity to cardiovascular (CV) morbidity and mortality in high risk patient cohorts with CKD, ESRD and HF. The availability of a highly effective catheter-based ultrasound device to selectively target renal nerves provides a potential unique opportunity to improve CV outcomes in these patients, a proposition that now needs to be tested in initial pilot trials and subsequent appropriately designed randomized controlled trials.
- Being tested
- Renal Denervation
- Keywords
- Renal Denervation, Sympathetic Nervous System
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationDevice
All eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease | Experimental | Renal Denervation Receives: Device: Renal Denervation |
| Heart Failure | Experimental | Renal Denervation Receives: Device: Renal Denervation |
| End stage renal disease | Experimental | Renal Denervation Receives: Device: Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in renal sympathetic nerve activity
Spillover results
Measured: BASELINE TO 3 MONTHS
Reduction in renal sympathetic nerve activity
Muscle Sympathetic Nerve Activity (MSNA)
Measured: BASELINE TO 12 MONTHS
Secondary outcomes (1)
Blood Pressure
Changes in systolic and diastolic blood pressures
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start8 Oct 2021
- Primary completion18 May 2025 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Perth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ReCor Medical, Inc.
- Responsible party
- Principal investigator, Professor Markus Schlaich, Royal Perth Hospital
- Investigators
- Markus Schlaich, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703620
- Sponsor's protocol ID
- DHC20190025
- Acronym
- RESURRECT
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REducing Sympathetic Activity Through Ultrasound-based Renal deneRvation in Excessive Cardiovascular Risk populaTions - the RESURRECT Trial. A Pilot Proof-of-concept and Safety Study With the Paradise Denervation System
- ClinicalTrials.gov ID
- NCT05703620
- Acronym / sponsor ID
- RESURRECT / DHC20190025
- Keywords
- Renal Denervation, Sympathetic Nervous System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Royal Perth HospitalUniversity, hospital or other
- Collaborators
- ReCor Medical, Inc.
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The is a non-randomized pilot trial, open-label evaluation of the physiologic response of native kidney denervation using the Paradise denervation system in CKD, End Stage Renal Disease (ESRD), and Heart failure (HF)
Detailed description
There is unequivocal evidence for an important contribution of increased renal sympathetic nerve activity to cardiovascular (CV) morbidity and mortality in high risk patient cohorts with CKD, ESRD and HF. The availability of a highly effective catheter-based ultrasound device to selectively target renal nerves provides a potential unique opportunity to improve CV outcomes in these patients, a proposition that now needs to be tested in initial pilot trials and subsequent appropriately designed randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | Experimental | Device: Renal DenervationRenal Denervation |
| Heart Failure | Experimental | Device: Renal DenervationRenal Denervation |
| End stage renal disease | Experimental | Device: Renal DenervationRenal Denervation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both Male and female patients
- Ages between 18-75 years of age
- Individual is competent and willing to provide written, informed consent to participate in this clinical study with either
Key exclusion criteria (10 listed)
- Ineligible anatomy
- Prior treatment with other devices for hypertension including but not limited to ROX Coupler (ROX Medical) , Mobius stent, and/or the CVRx (CVRx Inc) barostimulator device.
- Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
- Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
- Individual has clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal DenervationAll eligible participants receive ultrasound based renal denervation to both kidneys on all eligible vessels | Device | Chronic Kidney Disease, End stage renal disease, Heart Failure |
Primary outcome
Reduction in renal sympathetic nerve activity
Time frame: BASELINE TO 3 MONTHS
Spillover results
Reduction in renal sympathetic nerve activity
Time frame: BASELINE TO 12 MONTHS
Muscle Sympathetic Nerve Activity (MSNA)
1 secondary outcome
Blood Pressure
Time frame: Baseline to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schlaich principal investigator
Royal Perth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation in people with Chronic Kidney Diseases and Heart Failure, run by Royal Perth Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anu Joyson (92240390, anu.joyson@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in renal sympathetic nerve activity (time frame: BASELINE TO 3 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.